Implantable medical devices have been developed to treat a wide variety of conditions. Such devices may deliver controlled quantities of drugs, stimulate nerves, or control muscles. In particular, devices have been developed to treat the diseased or malfunctioning heart.
It has long been known that the heart muscle provides its pumping function in response to electrical events which occur within the atrium and ventricle of the heart. Conductive tissue connects the atrium and the ventricle and provides a path for electrical signals between the two areas. In a normal heart, a natural atrial event spontaneously occurs in the atrium and a corresponding ventricular event occurs later in the ventricle. Synchronized electrical events occurring naturally in the atrium and ventricle cause the heart muscle to rhythmically expand and contract and thereby pump blood throughout the body.
In a diseased heart, atrial and ventricular events may not naturally occur in the required synchronized manner and the pumping action of the heart is therefore irregular and ineffective to provide the required circulation of blood. The required synchronized activity of such diseased hearts can be maintained by an implanted cardiac pacemaker which applies synchronized stimulating pulses to either the atrium or ventricle or both.
A diseased heart may also beat unusually quickly, a condition known as tachycardia, or may lapse into a rapid, disorganized quivering known as fibrillation. The former condition is undesirable; the latter condition may be fatal. To correct these conditions, implantable cardioverters and defibrillators have been proposed. Like the related cardiac pacemaker, these devices monitor the electrical condition of the heart and provide a corrective electrical therapy to correct the improper heart function. The three functions of pacing, cardioverting and defibrillating, or any of them, may be incorporated into a single device, generically referred to as an implantable cardiac stimulator.
Cardiac stimulators are battery powered and, consequently, have a finite life before battery depletion may be expected. In addition to the battery, other components of the cardiac stimulation system may fail, such as leads, electrodes, or other system components. As an example of another type of change, the sensitivity of a patient's heart to electrical stimulation may change over time, altering the so-called threshold level for electrical stimulation. Such change of condition requires adaptation of the therapy delivered by the implantable cardiac stimulator, either automatically or by intervention by the attending physician. In any of these situations, or others, it may be deemed desirable to alert the patient to a changed condition so that action may be taken. For example, a pacemaker may detect the approaching end-of-life of its battery, in a known manner. It is desirable to alert the patient to this condition. Moreover, in the case of implantable defibrillators, delivery of therapy can be traumatic. It is sometimes deemed important to alert the patient to the prospect of eminent delivery of therapy.
Cardiac stimulators which alert or warn the patient of such conditions are known in the art. For example, such a device is described by Dutcher, et al. in U.S. Pat. No. 4,140,131. In the device described by Dutcher, et al., a device-controlled switch is activated to enable a specialized electrode adjacent the pacemaker to stimulate the patient's muscles to twitch. The nature of the electrode is not described in detail, but Ferek-Petrick, in U.S. Pat. No. 5,076,272, described the electrode of Dutcher, et al., as an auxiliary electrode surrounded by the indifferent electrode and fixed on the pacemaker can. In contrast, Ferek-Petrick, in U.S. Pat. No. 5,076,272, describes a cardiac stimulator with patient warning with an electrode affixed to the header of the stimulator. Another electrode is described in our U.S. patent application Ser. No. 08/426,949, filed Apr. 21, 1995, also assigned to Intermedics, Inc.
In yet another commonly assigned U.S. patent application Ser. No. 08,532,929, filed Sep. 22, 1995, a suture point or hole, commonly provided on a header of a stimulator, is modified to provide an electrical connection. An electrically conductive suture can then be used to secure the stimulator and to provide a connection for stimulus of the skeletal muscles of the patient to produce an effective twitch. The disclosure of that application is incorporated herein by reference.
In any of these configurations, the desired result is a noticeable reaction in the skeletal muscles of the patient sufficiently strong to alert the patient, but not painful. Patients differ from one another, however, and stimulation sufficient to cause a satisfactory reaction in one patient may be either insufficient or excessive in another. Moreover, the contact between an implanted device and surrounding tissue may change over time, with the result that a stimulation of a particular magnitude may have a different and unpredictable result. Also, the sensitivity of skeletal muscle to stimulation may change. U.S. patent application Ser. No. 08/549,050 describes a cardiac stimulator with a patient warning apparatus which automatically adjusts the magnitude of applied stimulus to achieve a desired level of reaction.
Although the level of reaction of the patient to a stimulus is important in assuring that the patient will actually receive a warning of changed condition, we believe that a patient will be more likely to perceive and appreciate a warning stimulation if that stimulation is delivered at a preselected time of day and particularly at a time when the patient is not likely to be sleeping or otherwise less likely to perceive a stimulus. It is the principle object of our invention, therefore, to provide a cardiac stimulator with patient warning apparatus which will warn the patient at a preselected time of day, rather than merely upon the occurrence of the preselected condition. It is also an object of our invention to provide such a cardiac stimulator which can dynamically adjust such a real time warning period to adapt for the circadian rhythm of the patient, or changes in wake-sleep patterns of the patient. It is also an object of our invention to provide a cardiac stimulator which distinguishes between conditions for which a warning must be given immediately upon the occurrence of the condition, and other conditions for which a warning can be postponed to a preselected time of day.